The present invention relates generally to implantable medical devices (“IMDs”), and more particularly to systems, devices and methods for rendering IMDs more safe in the presence of strong electro-magnetic interference, such as those produced by a magnetic resonance imaging (“MRI”) system.
IMDs can be used to provide a number of different medical therapies to patients. For example, therapeutic IMDs can include pacemakers, implantable cardioverter defibrillators (“ICDs”), blood pumps, drug delivery devices, neurostimulating devices, and the like. Some of the most common IMDs include pacemakers and ICDs (collectively referred to as cardiac rhythm management (“CRM”) devices), which are used to control the heart rate when heart rhythm disorders occur.
Magnetic resonance imaging (MRI) is an efficient technique used in the diagnosis of many disorders, including neurological and cardiac abnormalities and other diseases. MRI has achieved prominence in both the research and clinical arenas. It provides a non-invasive method for examining internal body structures and functions. Because MRI has become such a useful diagnostic tool, it now is used extensively in hospitals and clinics around the world.
As one skilled in the art will appreciate, MRI systems produce extensive electromagnetic fields during operation. In particular, MRI systems generally produce (and utilize) three types of electromagnetic fields: 1) a strong static magnetic field; 2) a time-varying gradient field; and 3) a radio frequency (RF) field which consists of RF pulses used to produce an image. The static field produced by most MRI systems has a magnetic induction ranging from about 0.5 to about 1.5 T. The frequency of the RF field used for imaging is related to the magnitude of the static magnetic field, and, for current-generation MRI systems, the frequency of the RF field ranges from about 6.4 to about 64 MHz. The time-varying gradient field is used in MRI for spatial encoding, and typically has a frequency in the Kilohertz range.
These strong electromagnetic fields produced by MRI systems can cause problems for implantable medical devices, such as CRM devices. For example, the static magnetic field can affect the magnetically controlled (reed) switch that prevents inappropriate programming of a pulse generator (“PG”), and in some cases, it can saturate the core of inductive switching power supplies, causing difficulties for some implantable device power supplies. Further, the time-varying gradient field can generate significant voltage in CRM device leads, which can cause false cardiac event sensing. Finally, some tests have shown that the RF field produced in MRI systems can cause CRM device heating, and voltage generation in the CRM device circuitry and leads. Of particular concern are the MR-induced voltages, which potentially can inhibit pacing and/or ICD defibrillation, or which can induce excessively rapid pacing and/or inappropriate ICD defibrillation shocks. Both of these malfunctions can be life-threatening events. Indeed, some deaths have been reported for patients with implanted CRM systems who were inadvertently subjected to MRI scans. As a result, both the U.S. Food and Drug Administration (FDA) and many pacemaker manufacturers have issued warnings against pacemaker recipients undergoing MRIs.
Also, as one skilled in the art will appreciate, the adverse effects of MRI fields are not limited to CRM devices. MRI fields can adversely affect other IMDs, as well. Thus, a need exists for systems, methods, and/or devices that can mitigate the hazards associated with using CRM devices and other IMDs in an MRI environment.